NCT03039855

Brief Summary

To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
6 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

January 16, 2017

Last Update Submit

September 23, 2025

Conditions

Mitral Valve Regurgitation

Keywords

MitralRegurgitationHeart valveTranscatheterTransapicalFunctionalDegenerativeTMVR

Outcome Measures

Primary Outcomes (3)

  • Freedom from all-cause mortality

    30 days

  • Freedom from major adverse events

    30 Days

  • Reduction of Mitral Regurgitation to optimal or acceptable

    30 days

Secondary Outcomes (10)

  • Freedom from all-cause mortality

    90 days, 180 days, one year and annually to five years

  • Freedom from major adverse events

    90 days, 180 days, one year and annually to five years

  • Technical success

    Day 0

  • Procedural success

    30 days

  • Device success

    Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years

  • +5 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system

Device: TIARA valve and transapical delivery system

Interventions

TIARA valve and transapical delivery systemDEVICE

Transcatheter mitral valve replacement

Also known as: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe mitral regurgitation
  • High surgical risk for open mitral valve surgery
  • Subject meets anatomical eligibility criteria

You may not qualify if:

  • Deemed too frail by objective frailty assessments
  • Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
  • Unsuitable cardiac structure
  • Clinically significant untreated Coronary Artery Disease (CAD)
  • Subjects on chronic dialysis
  • Pregnant or planning pregnancy within next 12 months
  • Documented bleeding or coagulation disorders
  • Active infections requiring antibiotic therapy
  • Subjects with a life expectancy less than 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Kerckhoff Klinik Herzzentrum-Herzchirurgie

Bad Nauheim, 61231, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Schüchtermann-Klinik

Bad Rothenfelde, 49214, Germany

Location

Deutches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Immanuel Klinikum Bernau und Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

St.-Johannes-Hospital, Klinik für Innere Medizin I

Dortmund, 44229, Germany

Location

Universitätsklinikum Halle

Halle, 06120, Germany

Location

Universitasklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg

Rotenburg an der Fulda, Germany

Location

Sana Herzchirurgie Stuttgart GmbH

Stuttgart, 70174, Germany

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.

Roma, RM, 00168, Italy

Location

Fondazione Toscana 'Gabriele Monasterio'

Massa, 54100, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Edinburgh Heart Centre Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

King's College Hospital

London, SE59RS, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Mitral Valve InsufficiencyGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2017

First Posted

February 1, 2017

Study Start

March 8, 2017

Primary Completion

December 19, 2019

Study Completion

August 6, 2024

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

DE(11)IT(4)ES(1)NL(1)IL(1)GB(2)